What are the responsibilities and job description for the Environmental Monitoring Lead Technician (Mon-Thurs 10p-9a) position at Fagron?
Who We Are
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.
About The Job
This position will work both independently and with the team to provide oversight of staff training and an in-depth understanding of environmental monitoring of cleanroom as well as sample performance, training, accountability, EMS (Environmental Monitoring System) oversight, CFU (Colony Forming Units) inspection, and overall cleanroom contamination control. In addition, the Environmental Monitoring Lead Technician can conduct investigations associated with monitoring responsibilities as well as be able to assist with internal/external audits.
Key Responsibilities
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
Ready for the challenge?
Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.
About The Job
This position will work both independently and with the team to provide oversight of staff training and an in-depth understanding of environmental monitoring of cleanroom as well as sample performance, training, accountability, EMS (Environmental Monitoring System) oversight, CFU (Colony Forming Units) inspection, and overall cleanroom contamination control. In addition, the Environmental Monitoring Lead Technician can conduct investigations associated with monitoring responsibilities as well as be able to assist with internal/external audits.
Key Responsibilities
- Carry out responsibilities in accordance with the organization’s policies, procedures, state, federal, and local laws.
- Understand and provide training on current and upcoming regulatory standards pertaining to Environmental Monitoring and Quality Manufacturing.
- Work cooperatively as an individual contributor and as a team member.
- Communicate effectively with EM personnel, cross-functional peers, and management.
- Assist in troubleshooting issues as they arise as well as performance enhancement opportunities.
- Perform Environmental Monitoring as needed.
- Ensure regulatory and company compliance is maintained.
- Evaluate environmental/personnel monitoring based on an established training course plan.
- Complete and assist with EM deviation investigations.
- Provide direct oversight of processes and personnel completing tasks which includes feedback and coaching.
- Create and maintain workflow that prepares EM technicians for their assigned duties and tasks.
- Recruit and select new hires by attending and participating in interviews.
- Perform all other duties as assigned.
- Prefer a degree in scientific discipline or equivalent and relevant work
- Understanding of the contamination prevention and fundamental understanding of microorganisms
- Knowledge and understanding of cGMP’s, FDA regulations and industry guidelines.
- Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel as well as align team members around shared goals.
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
- Strong interpersonal skills with the ability to interact with personnel at all management levels in a team environment.
- Ability to respond to challenges and additional projects in an understanding, positive, and objective manner.
- Demonstrate adaptable to dynamic conditions, work practices, and project timelines.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
Ready for the challenge?
Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.